Adapting Guidelines for Emergencies in the

Digital Age

Session 176, February 13, 2019

Maria Michaels, MBA, PMP, Public Health Advisor, Centers for Disease Control

& Prevention

Sharon Pacchiana, FNP, MSN, MHA, MMI, Principal Health Systems Analyst,

Health Informaticist, The MITRE Corporation

Maria Michaels MBA, PMP, Public Health Advisor

Centers for Disease Control & Prevention

Has no real or apparent conflicts of interest to report.

The findings and conclusions in this presentation are those of

the authors and do not necessarily represent the official

position of the Centers for Disease Control and Prevention.

Conflict of Interest

Sharon Pacchiana, FNP, MSN, MHA, MMI, Principal Health

Systems Analyst, Health Informaticist

The MITRE Corporation

Has no real or apparent conflicts of interest to report.

Conflict of Interest

• Adapting Clinical Guidelines for the Digital Age

– Today’s Guideline Development and Implementation

– A Multi-stakeholder Approach for a Future State That Helps

Overcome Current Challenges

Agenda

• Use Case: Development of Clinical Decisions Support (CDS) for

Anthrax Emergencies

– Overarching Anthrax Clinical Decision Support Development

Approach

– Anthrax CDS Development and Lessons Learned

• Role of Local Health Care Systems

• Summary

• Discuss the efforts led by CDC on Adapting Clinical

Guidelines for the Digital Age

– Explore a new process for sharing guidelines that

translate scientific evidence into practice more easily,

quickly, accurately, and consistently

– Enable rapid translation in support of emergency

preparedness and response

Learning Objectives

• Describe the process, challenges, opportunities, and

lessons learned in developing CDS for anthrax

• Identify the role of local health systems in integrating CDS

for non-routine biological exposures with their clinical

workflows and electronic health records (EHRs)

Imagine you are a health care worker in a community hospital and

have just been advised that you will be receiving patients exposed

to anthrax in a mass casualty event.

How would you respond as patients started showing up in your

emergency department?

You reached out to public health authorities to get guidance and

recommendations in real-time…

…but the recommendations are dozens of pages long, in prose.

Scenario

How do you ensure treatment consistent with clinical guidelines?

Now Imagine a Future…

 Clinical guidelines are expressed as executable code-based

clinical decision support (CDS) that can be integrated into

EHR systems in real time

– Guidelines expressed consistently across implementation

sites

– Executability forces precision in guideline implementation

– Reduced (or eliminated) redundant implementation

efforts across sites

Clinical Guidelines of the Future

Adapting Clinical

Guidelines for the

Digital Age

STUDY

ACTPLAN

Ensure clinical guidelines are followed consistently

to improve public health outcomes

Feedback Loop

Today’s Guideline Development and Implementation

Long Implementation Time

Research

Results

Literature

Review

Guideline

Narrative

Develop Guidelines Interpret & Implement Guidelines:

Local Level

Performed by up to 95% of ~5500 hospitals

Interpret & Implement

Guidelines: Across

Health Systems

Performed by up to 82% of ~355,000 clinics

Meta-

analysis

https://dashboard.healthit.gov/quickstats/quickstats.php

• Guideline authors

• Health IT developers

• Communicators

• Clinicians

• Patients / Patient Advocates

• Medical Societies

• Public Health Organizations

• Evaluation experts

• Standards experts

• Clinical decision support developers

• Clinical quality measure developers

• Policy or technical support for

implementation

Integrating Stakeholder Groups

Adapting Clinical Guidelines for the

Digital Age

Problem: Long Lag Time,

Inconsistencies, and

Inaccuracies in Translation

Contributes to an average of 17

years for scientific evidence to

apply in patient care

Reason: Playing the

“Telephone Game”

Multiple translations of guidelines

add complexity, opportunity for

error, and variation across

sites/providers

Solution: Developing Tools

and Guidelines Together

Can help evidence apply to

patient care more easily, quickly,

accurately, and consistently

https://www.cdc.gov/ophss/WhatWeDoACG.html

Redesigning Guideline

Development and Implementation

CURRENT STATE PROPOSED FUTURE STATE

Guidelines

CDS

Patient Care

10s-100s of

translations

100s-1000s of

translations

Guidelines

Informatics

Communications

Implementation

Evaluation

Concurrent

guideline

development

and translation

& upfront

planning

Local Implementation

Patient Care

Inconsistent (or nonexistent)

feedback loop

Consistent feedback

loop

Translating Evidence to Executable

CDS

Knowledge

Level

Description Example

Narrative

guideline

Guideline for a specific disease that is written in the format of a

peer

-reviewed journal article

Semi

structured

Flow diagram, decision tree, or other similar format that describes

recommendations for implementation

Structured

Standards

-compliant specification encoding logic with data

model(s), terminology/code sets, value sets that is ready to be

implemented

Executable

CDS implemented and used in a local execution environment (e.g.,

CDS that is live in an electronic health record (EHR) production

system) or available via web services

Use Case:

Development of

CDS for Anthrax

Emergencies

Overarching CDS Development Approach

Develop Clinical Decision Support Artifact

Research

Results

Literature

Review

Meta-

analysis

Narrative

Guideline(s)

Level 1 (L1) Development

Test Artifact

Pilot with

synthetic data

Conduct clinical pilot

Structured Code

Level 3 (L3) Development

Internal Validation

Testing

Implementation Guide

Semi-Structured

Logic

Level 2 (L2) Development

Value Sets

Level 4 (L4) Development

Implement Artifact

Level 2 Semi-structured Representation

1. Identified

Pertinent

Guidelines

3. Assessed Guidelines

per

Defined Criteria

4. Assessed

Recommendation

Statement(s) to Derive

Artifact

2. Developed Skeletal Clinical

Flow to Visualize Guidelines &

Focal Areas

Anthrax Post-Exposure Prophylaxis (PEP) for Asymptomatic Patients

5. Documented Detailed Clinical Workflow

with Semi-structured Representation of

CDS

(initially narrowed to 7 guidelines)

(17 total)

(selected 5 guidelines)

Level 3 Iterative Development and

Testing

• Based on L2 semi-structured logic and value sets,

– Developed CDS code in the Clinical Quality Language (CQL)

representation for clinical concepts), such as order sets and alerts

– Incrementally tested (test-driven development)

* Not the same

as those used in

synthetic pilot

1. Generated 100 synthetic patient records using

Synthea

– Synthea

• Synthea™ is an open-source tool for

generating synthetic patient records

• Provides statistically and

demographically accurate patient medical

history records that are free from cost,

privacy, and security concerns

Level 3 Synthetic Pilot

2. Executed CDS CQL against patient records and record outputs

– Main output was a potential order set plus potential alerts

– All formatted as appropriate FHIR resources

3. Clinical SMEs evaluated CDS outputs

– Compared treatment and alerts generated by CDS to the

documented clinical recommendations

Final Anthrax CDS for Anthrax Post-

Exposure Prophylaxis

Complex CDS

artifact with:

• 8 value sets

• 105 CQL

expressions

• 232

dependencies

• 1215 lines of

code

Detailed L2

Detailed L3

Anthrax CDS Published

• Metadata

• CQL

• Built-in synthetic test

patients

• Implementation

guide

• Validation report

https://cds.ahrq.gov/cdsconnect/artifact/anthrax-post-exposure-prophylaxis

L2 & L3 Challenges & Recommendations

Appropriate model to represent

clinical concepts

>Use proper FHIR resources so that the L3 accurately

represents clinical concepts

Inability to use actual patient data

for testing

>Use methodology (e.g. Synthea) to generate random

patient records to test logic

Proper error tracking

>Have a sequential iterative process for development

and the ability to trace errors

Issue Recommendation

Uncertainty of or conflicting guidance >Involve guideline developers with the L2 team

Multiple overlapping guidelines

>Define a systematic process for evaluating each

guideline and recommendation

>Develop a skeletal clinical workflow chart to visualize

the interrelationships

Complex clinical guidance

>Develop detailed clinical flow chart with semi-

structured representation

L2/L3 must align

>Have a robust ongoing mechanism for communicating

between L2 and L3 teams

Critical Success Factors in Developing

Clinical Decision Support

Critical elements for developing guidance into semi-structured

and structured guidance, then executing it in clinical systems

2. Education to each on all aspects of the process to ensure a

foundational understanding of the entire CDS development

process

1. Continual involvement throughout the process as a team

– Guideline creators

– Clinical artifact developers

– Technical artifact developers

– Health care system personnel implementing artifact

• Identify population health threats and prioritize CDS to address

these threats

• Include multiple facilities in developing or selecting CDS for

population health emergencies

• Follow a standardized method of implementing guidelines into

clinical workflows.

• Incorporate artifact implementation for disaster responses into an

integrated delivery network

• Pilot in a large-scale emergency preparedness exercise using a

simulation built into the test environments at a variety of sites with

multiple EHR platforms in order to determine if there are any

challenges to resolve for local implementation

Role of Local Health Care Systems

Clinical Guidelines of the Future

Contribute to the Adapting Clinical

Guidelines for the Digital Age

Implementation Guide

(http://build.fhir.org/ig/cqframework

/cdc-acg/index.html)

Maria Michaels, MBA, PMP

Centers for Disease Control and Prevention

maria.michaels@cdc.gov

(o) 404-498-0997

Sharon Pacchiana, FNP, MSN, MHA, MMI

The MITRE Corporation

spacchiana@mitre.org

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Questions

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Guidelines Related to Anthrax

Considered

Infection Control

 Guidance for Protecting Responders’ Health During the

First Week Following A Wide-Area Aerosol Anthrax Attack

(2012)

 Occupational Health Guidelines for Remediation Workers

at Bacillus anthracis-Contaminated Sites (2002)

 Clearance Strategy for Environments Contaminated with

Bacillus anthracis (2012)

 Guideline for Isolation Precautions: Preventing

Transmission of Infectious Agents in Healthcare Settings

(2007)

 Medical Examiners, Coroners, and Biologic Terrorism: A

Guidebook for Surveillance and Case Management (2004)

Laboratory

 Recommended Specimens for Microbiology and Pathology

for Diagnosis of Anthrax (2017)

 Biosafety in Microbiological and Biomedical Laboratories

(2009)

 Guidelines for Safe Work Practices in Human and Animal

Medical Diagnostic Laboratories (2012)

Prevention

• CDC Guidance: Anthrax Vaccine Adsorbed (AVA)

Post-Exposure Prioritization (2013)

• Use of Anthrax Vaccine in the United States:

Recommendations of the Advisory Committee on

Immunization Practices (ACIP) (2010)

Treatment

• Prevention and Treatment of Anthrax in Adults:

Results of CDC Expert Panels (2014)

• Special Considerations for Pregnant and Postpartum

Women (2014)

• Pediatric Anthrax Management (2014)

• Emergency Use Instructions (EUI) for Doxycycline for

Post-exposure Prophylaxis (PEP) of Anthrax (2017)

• Emergency Use Instructions (EUI) for Ciprofloxacin for

Post-exposure Prophylaxis (PEP) of Anthrax (2017)

Mass Casualty

• Clinical Framework and Medical Countermeasure Use

During an Anthrax Mass-Casualty Incident (2015)

• Identifying Meningitis During an Anthrax Mass Casualty

Incident: Systematic Review of Systemic Anthrax Since

1880 (2016)

Yellow highlights = those guidelines

used (5 total)